CLASS II Drug recall · Reported 7 Nov 2012 · FDA Enforcement Report
Leucovorin Calcium Injection USP, single use vials, 10mg/mL recalled
Ben Venue Laboratories is recalling Leucovorin Calcium Injection USP, single use vials, 10mg/mL, distributed nationwide in the US. The recall was initiated on 5 Jul 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-036-2013
- FDA event ID
- 62490
- Recalling firm
- Ben Venue Laboratories, Bedford, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2012
- FDA classified
- 1 Nov 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Jul 2012 | Recall initiated by company | |
| 1 Nov 2012 | Classified by FDA | +119 days |
| 7 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Product as listed by the FDA
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Which lots are affected?
Lot #, 2017619 (Bedford), Mfr Item # 0967-57-2017619, NDC, 55390-009-01, Exp. Date 11/2012; Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01; Lot #, 2017621 (Bedford), Mfr Item # 0967-57-2017621, NDC, 55390-009-01, Exp Date 01/2013; Lot #2038374, exp. 2/2013, NDC #55390-009-01; Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling); Lot #, 2038375 (Bedford), Mfr Item # 0967-57-2038375, NDC, 55390-009-01, Exp Date 03/2013; Lot #, 2065418 (Bedford), Mfr Item # 0967-57-2065418, NDC, 55390-009-01, Exp Date 06/2013; Lot #, 2067176 (Bedford), Mfr Item # 0967-57-2067176, NDC, 55390-009-01, Exp Date, 06/2013; Lot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr Item # 0967-57-2067178A, NDC, 55390-826-01, Exp Date, 06/2013.
Where was it sold?
Nationwide and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Leucovorin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 100 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |